Clinical Affairs Specialist III

About the role

At Integer, our values guide everything we do. They are Customer, Innovation, Collaboration, Inclusion, and Candor, all underpinned by Integrity.

Responsibilities

• Contribute to global clinical strategies to support clinical evidence requirements for product submissions and post-submission activities.
• Represent the Clinical Affairs function on product development teams.
• Work directly with representatives from cross-functional areas in possibly multiple geographical locations.
• Ensure clinical data integrity in support of the quality and regulatory functional group needs.
• Generate interim and final reports.
• Support Integer initiatives with the development and upkeep of market-specific clinical training.
• Support investigator conferences to review findings and advise on direction.
• Interface with, and assure training of investigators/physicians, centre staff, and Integer Clinical Affairs staff.
• Support adequate monitoring is conducted on all clinical trials.
• Provide a clinical perspective and approval on field complaint investigations.
• Work with regulatory bodies for the purpose of facilitating regulatory approvals and queries.
• Support the development of Integer technology including objectives, strategy, scope, budget, and schedule from proof-of-concept research through post-market commercial phases.
• Perform other functions as required.

What You Will Be Measured By

• Active support of Integer's Environmental, Health, Safety programs and behavior-based safety programs.
• Defined Goals and Objectives specifying key projects and expected milestones to achieve.
• Sufficient clinical data arguments provided in clinical evaluation documents to support regulatory product approvals.
• Leverage clinical knowledge to support the growth team initiatives and contribute to revenue growth.
• Create and maintain market-specific clinical training.
• Maintain and continuously update State of the Art clinical processes.
• Support the Development and maintenance of the physician advisory board.
• Complete clinical inputs for product approval and product renewal within budget.
• Deliver projects on time for deliverables and within budget.
• Develop good written and oral communication skills.

Qualifications

• A degree from higher education (Science, Engineering, Health Science, Nursing or related field).
• 3 years of documented professional experience; or 5-7 years of documented professional experience if a degree is not a prerequisite for a given task.
• Experience in medical device industry or pharmaceutical industry including US and international medical device regulatory submissions/approvals.
• Experience with implantable devices and/or other high-risk device types.
• Knowledge and experience of clinical evaluations.
• Knowledge and experience with various medical device regulations such as the Medical Device Regulation (2017/21 CFR Part 812), and standards guidance documents such as MEDDEV 2.7.1 (rev 4), MDCG 2020 5, MDCG 2020 6, ICH Guidelines and their application.
• Experience working with the medical community including physicians.
• Knowledge of feasibility, pivotal, and post-market clinical trials.
• Ability to work independently and collaboratively within the organization.
• Experience working in ERP systems (such as Oracle, Reliance, etc.), Minitab, Excel, etc.
• Leadership skills with demonstrated ability to drive positive results and deliver projects on time for deliverables and within budget.

Benefits

• Total rewards program including base salary and a cash-based incentive program supporting pay-for-performance philosophy.
• Comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.
• Parental leave available after one year.
• Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity, and accident insurance.
• Immediate eligibility to participate in the 401(k) plan with company matching contributions.
• 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

Pay

$75,750 - $111,000

Schedule

N/A